ELITE: Early Versus Late Intervention Trial With Estradiol
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The purpose of this study is to examine the effects of oral 17B-estradiol (estrogen) on the progression of early (subclinical) atherosclerosis and cognitive decline in healthy postmenopausal women.
Condition | Intervention | Phase |
---|---|---|
Atherosclerosis |
Drug: Oral 17B-estradiol Drug: Placebo |
Phase 2 Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
Official Title: | Biologic Response of Menopausal Women to 17B-Estradiol |
- rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT) [ Time Frame: Twice at baseline and then every 6 months on trial ] [ Designated as safety issue: No ]
- neurocognitive function [ Time Frame: Baseline and at 3 years and end of randomized treatment ] [ Designated as safety issue: No ]
- cardiac computed tomography [ Time Frame: End of randomized treatment ] [ Designated as safety issue: No ]measurement of coronary artery calcium and coronary artery lesions
Enrollment: | 643 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | July 2013 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: 17B-estradiol
Oral 17B-estradiol 1 mg daily
|
Drug: Oral 17B-estradiol
Oral 17B-estradiol 1 mg daily
Other Names:
|
Placebo Comparator: Placebo
Matched placebo oral 17B-estradiol daily
|
Drug: Placebo
Matched placebo oral 17B-estradiol
|
Detailed Description:
The primary hypothesis to be tested is that 17B-estradiol (estrogen) will reduce the progression of early atherosclerosis if initiated soon after menopause when the vascular endothelium (lining of blood vessels) is relatively healthy versus later when the endothelium has lost its responsiveness to estrogen. Ultrasonography will be used to measure the rate of change in the thickness of the carotid artery and cardiac computed tomography (CT) will be used to measure coronary artery calcium and coronary artery lesions. The second hypothesis to be tested is that 17B-estradiol (estrogen) will reduce the progression of cognitive decline if initiated soon after menopause when healthy brain tissue remains responsive to estrogen versus later when brain tissue has lost its responsiveness to estrogen.
A total of 643 (actual)(504, initially proposed) postmenopausal women were randomized according to their number of years since menopause, less than 6 years or 10 years or more, to receive either oral 17B-estradiol 1 mg daily or a placebo. Women with a uterus will also use vaginal progesterone gel 4% (or a placebo gel) the last ten days of each month. The vaginal progesterone will be distributed in a double-blind fashion along with the randomized treatment so that only women exposed to active treatment will receive active progesterone. As initially proposed, participants will undergo ultrasonography at baseline and every 6 months throughout the 2 to 5 years (average 3 years) of randomized treatment. Participants will also undergo cognitive testing at baseline and after 3 years of randomized treatment. The trial has been extended for an additional 2 to 2.5 years of randomized treatment (overall average randomized treatment of 5 years and range of 2 to 8.5 years). Ultrasonography will continue to be collected every 6 months and upon completion of randomized treatment, participants will undergo cardiac CT for coronary artery calcium and coronary artery lesion measurements. Participants will also undergo a third cognitive testing at the completion of randomized treatment.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women with a serum estradiol level 25 pg/ml or less
- No period for 6 months or more
- Postmenopausal less than 6 years, OR 10 years or longer
Exclusion Criteria:
- Clinical signs, symptoms, or personal history of cardiovascular disease
- Women who have had a hysterectomy only and no oophorectomy (since time from menopause cannot be determined)
- Diabetes mellitus or fasting serum glucose 140 mg/dL or greater
- Uncontrolled hypertension (diastolic blood pressure 110 mmHg or greater)
- Thyroid disease (untreated)
- Serum creatinine greater than 2.0 mg/dL
- Plasma triglyceride levels greater than 500 mg/dL
- Life threatening disease with prognosis less than 5 years
- Cirrhosis or liver disease
- History of deep vein thrombosis or pulmonary embolism
- History of breast cancer
- Current hormone replacement therapy (HRT)
United States, California | |
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine | |
Los Angeles, California, United States, 90033 |
Principal Investigator: | Howard N. Hodis, MD | University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine |
Additional Information:
No publications provided by University of Southern California
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Howard N. Hodis, MD, USC |
ClinicalTrials.gov Identifier: | NCT00114517 History of Changes |
Other Study ID Numbers: | AG0025, R01AG024154 |
Study First Received: | June 15, 2005 |
Last Updated: | June 17, 2010 |
Health Authority: | United States: Federal Government |
Keywords provided by University of Southern California:
atherosclerosis CAD cardiac computed tomography cardiovascular disease carotid artery intima-media thickness cognitive function computed tomography coronary artery calcium coronary artery disease |
coronary artery lesions CVD estrogen estrogen therapy hormone therapy postmenopausal subclinical vascular disease timing hypothesis ultrasonography |
Additional relevant MeSH terms:
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Estradiol Polyestradiol phosphate Estrogens Estradiol valerate Estradiol 3-benzoate |
Estradiol 17 beta-cypionate Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on October 15, 2012